An FDC drug, also known as combination drug, is a fixed-dose combination, which includes two or more active pharmaceutical ingredients (APIs), combined in a single dosage form, which is manufactured and distributed in fixed doses.
The vast medicinal potential of plants has been appreciated by humans long before recorded history.
Traditional medicine utilizing medicinal plants and plant extracts has been practiced for centuries in parallel to modern Western medicine. Among the more than 300,000 seed plants, some 60% have been utilized for therapeutic interventions, particularly in South America, Africa, and Asia.
Cannabis, more commonly known as marijuana, is a genus of flowering plants that includes at least three species, Cannabis sativa, Cannabis indica, and Cannabis ruderalis as determined by plant phenotypes and secondary metabolite profiles.
Several medicinal uses have been found for the active ingredients of cannabis, mainly the cannabinoids cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN), and cannabichromene (CBC). For example, treatment of nausea and pain associated with cancer and chemotherapy, nausea, pain associated with AIDS, arthritis and rheumatism, migraines, stress and depression, to mention a few.
Spilanthol, also known as affinin (C14H23NO, MW: 221.339 g/mol) is a secondary metabolite bioactive N-alkylamide compound found in many different plants having several biological properties and health effects. Spilanthol is present, for example, in the genus Heliopsis longipes also known as chilcuague and in several species in the genus Acmella, for example, A. oleracea, also known as paracress and jambu.
Like many plant-originated alkamides, spilanthol (affinin) presents various bioactivities, from helping to protect the plant to being an antioxidant, antimutagenic, anti-cancer, antinociceptive, anti-inflammatory, antimicrobial, antibacterial, antifungal, analgesic and endocannabinoid agonist.